Fast-track Surgery in the Treatment of Hirschsprung's Disease (Fast-track)

January 24, 2015 updated by: Jiexiong Feng, Tongji Hospital
To evaluate the safety and efficacy of Hirschsprung's disease

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The patients are divided into two groups：fast-track surgery combined with laparoscope group and laparoscope with traditional managements group.Postoperative recovery,hospital stay,hospital cost and complcations were compared.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. surgical treatment for Hirschsprung's disease
  2. The first procedure for Hirschsprung's disease
  3. Age<14 years

Exclusion Criteria:

  1. conservative treatment for Hirschsprung's disease
  2. The reoperation for Hirschsprung's disease
  3. Age>14 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fast-track Surgery
probiotics,oral,b.i.d.
Drug: probiotics
probiotics
Other Names:
  • Bifico
Active Comparator: Traditional Group
placebo,oral,b.i.d.
Drug: placebo
placebo
Other Names:
  • Bifico

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of participants with recovery of boewl movements
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of the hospital stay
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

Boston Children's Hospital

Investigators

  • Principal Investigator: Zhi Li, MD PhD, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

January 17, 2015

First Submitted That Met QC Criteria

January 24, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Estimate)

January 29, 2015

Last Update Submitted That Met QC Criteria

January 24, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tongji Fast-track surgery

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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